Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers

NCT01531517 | Terminated Phase 3 DMC

• 1 other identifier: Pedyphar2012
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

Clinical Trial Phase III-b Study Sponsor: European Egyptian Pharmaceutical Industries Sample Size: 120 patients (60 per arm) Study Population: Patients with Diabetic foot ulcer of any stage after proper surgical treatment - if needed. Those patients will be recruited from patients attending the Diabetic foot Center at Faculty of Medicine - Alexandria University and the outpatient clinic at Faculty of Medicine, Cairo University. Recruitment Period: 9 months Dose application: thick layer of 2-3 mm applied to the dressing then dressing applied to the ulcer. Endpoints: Complete healing of the ulcer OR 5 months of application of the ointment whichever comes first

Conditions

Diabetic Foot Ulcer

Keywords

Pedyphar; Ointment; Healing; Diabetic; Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Healing of the Ulcer

  within 5 months or complete healing whichever comes first

Secondary Outcomes (2)

• reduction of infection in the ulcer site

  5 months

• local reaction that may be due to study drug

  5 months

Study Arms (2)

Pedyphar

EXPERIMENTAL

Ointment

Drug: Royal Jelly and Panthenol (PedyPhar® Ointment)

Panthenol

ACTIVE COMPARATOR

Ointment

Drug: Panthenol Ointment

Interventions

Royal Jelly and Panthenol (PedyPhar® Ointment) DRUG

the following will be done to each patient depending on the number of the visit: 1. Assessment of the patient for inclusion/exclusion criteria 2. Informed consent process 3. Medical history of the patient 4. Blood withdrawn for investigation 5. Drainage of the ulcer if there is a collection 6. Revascularization as needed and indicated by APSV done at visit 0. 7. Swab from the ulcer for culture and micro-organism count: on detailed visits only. 8. Debridement as needed. 9. Dressing: * Inspection and assessment of the ulcer * Irrigation using 500 ml of saline or as required. * Drying of the ulcer (leave to dry) * Spread a layer of 3 - 5 mm of PedyPhar on a dressing and then apply the dressing to the ulcer * Fix the dressing to the ulcer

Also known as: Pedyphar, Panthenol, Royal Jelly, Ointment, Diabetic Foot Ulcer

Pedyphar

Panthenol Ointment DRUG

the following will be done to each patient depending on the number of the visit: 1. Assessment of the patient for inclusion/exclusion criteria 2. Informed consent process 3. Medical history of the patient 4. Blood withdrawn for investigation 5. Drainage of the ulcer if there is a collection 6. Revascularization as needed and indicated by APSV done at visit 0. 7. Swab from the ulcer for culture and micro-organism count: on detailed visits only. 8. Debridement as needed. 9. Dressing: * Inspection and assessment of the ulcer * Irrigation using 500 ml of saline or as required. * Drying of the ulcer (leave to dry) * Spread a layer of 3 - 5 mm of Panthenol on a dressing and then apply the dressing to the ulcer * Fix the dressing to the ulcer

Also known as: Panthenol, Ointment, Diabetic foot Ulcer

Panthenol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult diabetic foot syndrome subjects over 18 years of age of any sex
• All stages of diabetic foot syndrome including Wagner stage 5 - Mid-foot gangrene only after appropriate surgical treatment.
• Patients suffering from type 1 or type 2 diabetes mellitus with diabetic foot syndrome.
• Stable metabolic and pharmacological control at recruitment and during the trial period.
• Adequate perfusion of lower limb as measured by HHD and confirmed by APSV.

You may not qualify if:

• Non-diabetic foot ulceration (traumatic, thermal ulceration etc)
• Diabetic foot syndrome graded 5 on Wagner's scale - hind foot gangrene only.
• Any pathological state or disease which can affect the development and outcomes of diabetic foot syndrome such as liver cell failure and renal failure
• Severe limb ischemia (by clinical assessment and HHD) unless re-vascularized.
• Presence of slough or sequestrum unless debrided.
• Hemoglobin less than 8 g/dl unless corrected.
• Those receiving NSAIDs, steroids or anti-mitotic drugs.
• Septicemia patients requiring urgent amputation.

Sponsors & Collaborators

• European Egyptian Pharmaceutical Industries: lead

Study Sites (2)

Alexandria University Hospitals

Alexandria, Egypt

Location

Cairo University Hospitals

Alexandria, Egypt

Location

Related Publications (1)

• Yakoot M, Abdelatif M, Helmy S. Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study. Diabetes Metab Syndr Obes. 2019 Sep 2;12:1659-1665. doi: 10.2147/DMSO.S210680. eCollection 2019.

  PMID: 31564933 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer

Interventions

royal jelly; dexpanthenol; Ointments

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Samir H Assaad, PhD

  Alexandria University Hospitals

  PRINCIPAL INVESTIGATOR

• Hesham M Abdel Samad, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 13, 2012
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: February 20, 2015

Record last verified: 2012-02

Locations

EG (2)